A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Combination Treatment of Fimasartan/Atorvastatin in Patients With Essential Hypertension and Dyslipidemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- LDL-C
研究概览
简要总结
The objective of this clinical study is to evaluate the efficacy and safety by comparing the fimasartan/atorvastatin treatment group to the fimasartan/placebo treatment group and the placebo/atorvastatin treatment group respectively at Week 8 in patients with essential hypertension and dyslipidemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provided a written consent to participate in this clinical study
- •Male or female adults aged 19-70 years
- •Patients must have been confirmed essential hypertension and dyslipidemia at Screening visit (V1)
- •Uncontrolled blood pressure (140 mmHg ≤ mean SiSBP < 180 mmHg) at the pre- baseline visit (V2) after wash-out period
- •Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
排除标准
- •Severe hypertension with mean Sitting systolic blood pressure(SiSBP)≥180 mmHg or Sitting diastolic blood pressure(SiDBP) ≥110 mmHg at the screening visit (V1) and the pre-baseline visit (V2), or orthostatic hypotension accompanied by symptoms
- •Difference of Sitting systolic blood pressure(SiSBP) ≥ 20 mmHg and Sitting diastolic blood pressure(SiDBP) ≥ 10 mmHg between Lt and Rt arms for 3 consecutive times at the screening visit (V1)
- •Secondary hypertension patients: Secondary hypertension is not limited to the following diseases; (e.g., renovascular disease, adrenal medullary and cortical hyperfunctions, coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's syndrome, pheochromocytoma, and polycystic kidney disease)
- •Uncontrolled diabetes mellitus (currently on insulin, or HbA1c >9% at the pre-baseline visit (V2)), or uncontrolled hypothyroidism (TSH ≥1.5 times the upper limit at the pre-baseline visit (V2))
- •Heart disease (heart failure of New York Heart Association (NYHA) class 3 and 4), or ischemic heart disease (angina pectoris, myocardial infarction), peripheral vascular diseasenewly diagnosed within 6 months prior to the screening visit (V1), percutaneous transluminal coronary angioplasty, or coronary artery bypass graft, etc.
- •Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
- •Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant aortic valve stenosis or mitral valve stenosis
- •Cerebrovascular disorder (stroke, cerebral infarction, transient cerebral ischemic attack, cerebral hemorrhage, etc. within 6 months prior to the screening visit (V1)
- •Pregnant or lactating women
研究组 & 干预措施
Active Comparator 2
Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg
干预措施: Placebo for Fimasartan 120mg (Drug)
Experimental
Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
干预措施: Fimasartan 120mg (Drug)
Experimental
Co-administration of a fixed dose combination of Fimasartan 120mg and Atorvastatin 40mg
干预措施: Atorvastatin 40mg (Drug)
Active Comparator 1
Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
干预措施: Fimasartan 120mg (Drug)
Active Comparator 1
Co-administration of Fimasartan 120mg and Placebo for Atorvastatin 40mg
干预措施: Placebo for Atorvastatin 40mg (Drug)
Active Comparator 2
Co-administration of Atorvastatin 40mg and Placebo for Fimasartan 120mg
干预措施: Atorvastatin 40mg (Drug)
结局指标
主要结局
LDL-C
时间窗: 8weeks from Baseline Visit
The change in LDL-C from baseline in the test group at Week 8 compared to the active comparator group 1(fimasartan 120 mg)
SiSBP
时间窗: 8weeks from Baseline Visit
The change in Sitting systolic blood pressure(SiSBP) from baseline in the test group(Fimasartan 120mg/Atorvastatin 40mg) at Week 8 compared to the Active Comparator group 2(Atorvastatin 40mg)
次要结局
- LDL-C(8weeks from Baseline Visit)
- SiSBP(8weeks from Baseline Visit)